Nurofen Cold & Flu Film-Coated Tablets Ibuprofen 200mg Pseudophedrine hydrochloride 30mg

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Commercializzato da:

Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland

Codice ATC:

M01AE51

INN (Nome Internazionale):

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Tipo di ricetta:

OTC

Area terapeutica:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-02-28

Foglio illustrativo

NUROFEN COLD & FLU FILM COATED TABLETS
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Nurofen Cold & Flu
Film-Coated Tablets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
- If any of the side-effects gets serious, or if you notice any
side-effect not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Nurofen Cold & Flu Film-Coated Tablets are and what they are
used for
2. Before you take Nurofen Cold & Flu Film-Coated Tablets
3. How to take Nurofen Cold & Flu Film-Coated Tablets
4. Possible side-effects
5. How to store Nurofen Cold & Flu Film-Coated Tablets
6. Further Information
1.WHAT NUROFEN COLD & FLU FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR?
Nurofen Cold & Flu Film-Coated Tablets contain two active ingredients
which work together to
relieve the major symptoms of cold & flu: ibuprofen relieves pain,
reduces inflammation and lowers
temperature, whilst Pseudoephedrine Hydrochloride is an effective
decongestant to ease nasal and
sinus congestion. Nurofen Cold and Flu Film-Coated Tablets rapidly
relieves the headaches, aches
and the pain and fever commonly associated with colds and flu and
eases blocked noses, sinuses and
the pain of sore throats.
2. BEFORE YOU TAKE NUROFEN COLD & FLU FILM-COATED TABLETS:
DO NOT TAKE NUROFEN COLD & FLU FILM-COATED TABLETS IF YOU:
• are allergic to ibuprofen, pseudoephedrine hydrochloride, or any
of the ingredients of Nurofen
Cold & Flu Film-Coated Tablets listed in Section 6.
• have experienced shortness of breath, worsening of asthma,
allergic rash or an itchy, runny nose
or swelling of the lips, face, tongue or throat when taking ibuprofen,
codeine, aspirin or other

Scheda tecnica

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Cold & Flu Film-Coated Tablets
Ibuprofen 200mg
Pseudophedrine hydrochloride 30mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Quantity
Ibuprofen
200 mg
Psuedoephedrine Hydrochloride
30 mg
Excipients with known effect: Sunset yellow (E110), up to 16.8
micrograms per tablet.
For a full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet (Short term: tablet)
Yellow, circular, biconvex, tablets printed in black with an
identifying motif.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of head colds and influenza, including
nasal congestion and to ease the pain of sore throats.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For short-term use only.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to relieve
symptoms.
The patient should consult a doctor if symptoms persist or worsen, or
if the product is required for more than 3 days.
POSOLOGY
ADULTS: Initial dose two tablets, then if necessary 1 – 2 tablets
every four hours. Do not exceed six tablets in any 24 hour period.
PAEDIATRIC POPULATION:
CHILDREN OVER 12 YEARS OF AGE: As above for adults.
CHILDREN UNDER 12 YEARS OF AGE: Ibuprofen + pseudoephedrine
combination solid dose strength products are contraindicated
in children aged less than 12 years.
ELDERLY POPULATION: There is no indication that dosage needs to be
modified in the elderly. However, it may be advisable to
monitor renal and hepatic function and, if there is serious
impairment, caution should be exercised.
HEPATIC IMPAIRMENT: It may be advisable to monitor hepatic function.
The product should not be used in severe hepatic
failure (see section 4.3 and 4.4).
RENAL IMPAIRMENT: It may be advisable to monitor renal function. The
product should not be used in severe renal failure (see
section 4.3 and 4.4).
Page 2 of 11
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
Hyperse